Impressive new data from a sizeable study population suggests that OrbusNeich’s clever pro-healing Genous™ stent may perform as well without dual antiplatelet therapy as it does with it.
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View From The Med Week 25 Is Available Now
View From The Med is our weekly reflection on the events of the past seven days. This week has been a busy one as usual with a few gems. Enjoy.
Boston Scientific Brings In Ex-J&J Man To Lead China Team
Boston Scientific has appointed ex-J&J Ortho man Warren Wang as Vice President and Managing Director of its operations in China. Mr. Wang is responsible for leading the company’s team in China and executing the development strategy in the Chinese market.
First EU Patient For Boston’s Latitude™ NXT Remote Patient Management System
Boston Scientific Corporation has announced a significant milestone for its telemonitoring technology with the initial use of the Latitude NXT Remote Patient Management System for pacemaker patients in Europe. The company says its next-generation wireless remote patient management system enables physicians to risk-stratify patients and more confidently make treatment decisions.
More On Claret’s Embolic Protection Devices
A few days ago we covered the story of Claret Medical’s first-in-human study using its original CE Pro embolic capture device. At the time we felt there were a few unanswered questions, so went back to Claret for some more information. This after all is a very promising looking device with genuine patient welfare consequences.
FDA Provides Info On Boston Scientific’s Promus Element™ Plus Stent
FDA has provided useful information on the recently approved Promus Element™ Plus drug eluting stent family of products from Bostons Scientific.
Endoscopic Ablation For AF Gains Study Support
A new clinical study suggests endoscopic ablation for Atrial fibrillation generates good results with a durable outcome and a short learning curve for operators.
Renal Denervation: Just How Big Is The Bandwagon?
We seem to be writing about Renal Denervation every few weeks as the players unveil their latest approval of latest study result. So we thought it worth stepping back and considering the state of play for a moment.
First-in-Man Study Shows Embolic Debris Capture In >50% Of TAVI Patients Using Claret Filter
Neurological protection against emboli following TAVI is highly desirable, so Claret Medical’s early clinical experience in which over 50% of filter deployments resulted in capture of debris is reason for optimism.
First-in-Human Nonsurgical Percutaneous Bioprosthetic Mitral Heart Valve Implant
CardiaQ Valve Technologies has waited for the moment when its percutaneous mitral valve was first deployed in man, and it has now announced that’s occurred in what is believed to be a world first and a clinical milestone.
Paradise™Ultrasound-Based Renal Denervation System Shows 6 Month 33mmHg BP Reduction In Resistant Hypertension Patients
ReCor Medical has reported six-month follow-up data on eight patients who have been treated via renal denervation for their resistant hypertension with the company’s unique ultrasound-based system and the results are impressive with an average reduction in systolic blood pressure of 33mmHg.
FDA 510(k) Clearance For Cardiosolutions’ Dexterity™ Steerable Introducer
Cardiosolutions Inc., has announced that it has received FDA 510(k) clearance to market its Dexterity Steerable Introducer, a next generation structural heart access introducer and delivery conduit.
FDA Panel Votes To Extend Sapien Valve Indication To Include High-Risk Patients
It seems members of the FDA Circulatory Devices Advisory Panel have satisfied themselves that the benefits of Edwards’ Sapien heart valve outweighed the risks for as it voted 11-0 in favour of approval of the device for use in high risk patients. The final decision will now rest with FDA itself.
CE Mark And First Clinical Use For Endosense TactiCath® Quartz Force-Sensing Ablation Catheter
Endosense has announced that its TactiCath Quartz force-sensing ablation catheter has been CE mark approved. In cooperation with the company’s distributor Biotronik, first cases using the new device have been performed by renowned physicians at three centres across Europe.
Cordis Issues “Urgent” Recall On Fire Star Rx Balloon Catheters
J&J’s Cordis division is worried that one lot of its Fire Star Rx Balloon Catheters runs the risk of deflating too slowly or worse, not at all. The recall is limited to certain Far Eastern countries.
CardioFocus HeartLight Ablation Study Demonstrates Durable Pulmonary Vein Isolation In Treatment Of Atrial Fibrillation
CardioFocus, Inc.is drawing our attention to a study in the journal Heart Rhythm, demonstrating 98% acute success and durable pulmonary vein (PV) isolation rates achievable with a single, visually-guided HeartLight EAS ablation procedure.